Trastuzumab biosimilar is under clinical development by Prestige BioPharma and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Trastuzumab biosimilar’s likelihood of approval (LoA) and phase transition for Adenocarcinoma Of The Gastroesophageal Junction took place on 28 May 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 28 May 2021 increased Trastuzumab biosimilar’s LoA and PTSR for Gastric Cancer.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Trastuzumab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Trastuzumab biosimilar overview

Trastuzumab biosimilar is under development for the treatment of HER positive breast cancer and gastric cancer or gastroesophageal juction adenocarcinomas. The drug candidate is administered through intravenous route as a drip. Trastuzumab is a recombinant IgG1 kappa, humanized monoclonal antibody acts by targeting cells expressing HER2.

Prestige BioPharma overview

Prestige BioPharma (PBP) is a biopharmaceutical company that discovers and develops biosimilars and antibody therapeutics for oncology and immune disorders. The company is investigating HD201, a trastuzumab biosimilar targeting breast cancer and gastric cancer; HD204, a bevacizumab biosimilar to treat solid tumors; PBP1502, adalimumab biosimilar against arthritis; and PBP1510 for the treatment of pancreatic cancer. It is evaluating biosimilars and antibody therapeutics in the areas of bone loss, osteoporosis, macular edema, metastatic colorectal cancer, retinopathy, metastatic and unresectable melanoma and others. PBP is also engaged in development of vaccine-based therapeutics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The company has operations in Australia, Belgium, South Korea and, the US. PBP is headquartered in Singapore City, Singapore.

Quick View Trastuzumab biosimilar LOA Data

Report Segments
  • Biosimilar
Drug Name
  • Trastuzumab biosimilar
Administration Pathway
  • Intravenous Drip
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Pre-Registration

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.